A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease
Recruiting · NCT07174310 · Interventional (participants receive a specific treatment) · Lead sponsor: Hoffmann-La Roche
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboPrasinezumab
What this trial is about
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of prasinezumab compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.
Who can take part
Age range
50 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Body weight within 40-110 kilograms (kg) (88-242 pounds \[lbs\]) and a body mass index within the range 18-34 kg/m2
- Diagnosis of idiopathic PD based on Movement Disorder Society (MDS) criteria
- Has received monotherapy treatment
- An MDS-UPDRS Part IV score of 0 at screening and prior to randomization
- Hoehn and Yahr (H\&Y) Stage 1 or 2 off medication at screening and prior to randomization
- Agreement to adhere to the contraception requirements
Exclusion criteria
- Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
- Medical history indicating a parkinsonian syndrome other than idiopathic PD
- Diagnosis of a significant neurologic disease other than PD
- Chronic uncontrolled hypertension
Where it is running
60 locations listed across 29 US states.
- University of Alabama at Birmingham - Birmingham, Alabama, United States
- Barrow Neurological Institute - Phoenix, Arizona, United States
- Neurology Center of North Orange County - Fullerton, California, United States
- UC San Diego - La Jolla, California, United States
- Keck School of Medicine of USC - Los Angeles, California, United States
- UCLA Neurology Outpatient Clinic - Los Angeles, California, United States
- Parkinson?s Research Centers of America ? Palo Alto - Palo Alto, California, United States
- Profound Research LLC at The Neurology Center of Southern California - Pasadena, California, United States
- UCSF Weill Institute for Neurosciences - San Francisco, California, United States
- Stanford Neuroscience Health Center (SNHC) - Stanford, California, United States
- Rocky Mountain Movement Disorders - Englewood, Colorado, United States
- Institute for Neurodegenerative Disorders - New Haven, Connecticut, United States
- Georgetown University - Washington D.C., District of Columbia, United States
- JEM Research LLC - Atlantis, Florida, United States
- Parkinson's Disease and Movement Disorders Center of Boca Raton - Boca Raton, Florida, United States
- K2 - Villages - Lady Lake, Florida, United States
- K2 Medical Research-Maitland - Maitland, Florida, United States
- Baptist Hospital of Miami - Miami, Florida, United States
- Charter Research - Winter Park/Orlando - Orlando, Florida, United States
- Advent Health Orlando - Orlando, Florida, United States
- USF Parkinsons Disease and Movement Disorders Center - Tampa, Florida, United States
- Grady Memorial Hospital - Atlanta, Georgia, United States
- Hawaii Pacific Neuroscience - Honolulu, Hawaii, United States
- Northwestern University Feinberg School Of Medicine - Chicago, Illinois, United States
- University of Kansas Medical Center - Kansas City, Kansas, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Quest Research Institute - Farmington Hills, Michigan, United States
- Washington Uni School of Medicine - St Louis, Missouri, United States
- Cleveland Clinic Lou Ruvo - Las Vegas, Nevada, United States
- Renown Health - Reno, Nevada, United States
- Hackensack University Medical Center;Department of Neurology, Neuroscience Institute - Paramus, New Jersey, United States
- University of New Mexico - Albuquerque, New Mexico, United States
- Dent Neurological Institute - Amherst, New York, United States
- Parkinson's Research Centers of America - Long Island - Commack, New York, United States
- Weill Cornell Medical College - New York, New York, United States
- Columbia University Medical Center - New York, New York, United States
- Asheville Neurology - Asheville, North Carolina, United States
- Duke University Medical Center - Durham, North Carolina, United States
- NeuroCare Center - Canton, Ohio, United States
- Cleveland Clinic - Cleveland, Ohio, United States
- The Movement Disorder Clinic of Oklahoma - Tulsa, Oklahoma, United States
- Oregon Health and Science University - Portland, Oregon, United States
- University Pennsylvania Hospital - Philadelphia, Pennsylvania, United States
- Allegheny General Hospital - Pittsburgh, Pennsylvania, United States
- Avera Medical Group - Sioux Falls, South Dakota, United States
- Veracity Neuroscience - Memphis, Tennessee, United States
- Vanderbilt University Medical Center - Nashville, Tennessee, United States
- Texas Neurology PA - Dallas, Texas, United States
- Central Texas Neurology Consultants - Round Rock, Texas, United States
- University of Vermont Medical Center - Burlington, Vermont, United States
- University of Virginia Health System - Charlottesville, Virginia, United States
- VCU Health North Hospital - Richmond, Virginia, United States
- West Virginia University - Morgantown, West Virginia, United States
- Aarhus Universitetshospital Skejby - Aarhus N, Denmark
- Hospital Universitari Vall d Hebron - Barcelona, Spain
- Hospital Clinic Barcelona - Barcelona, Spain
- Kliniken Beelitz GmbH - Beelitz, Germany
- Beijing Friendship Hospital Affiliated of Capital University of Medical Science - Beijing, China
- Xuanwu Hospital, Capital Medical University - Beijing, China
- Beijing Tian Tan Hospital,Capital Medical University - Beijing, China
Showing 60 of 192 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →